Women of childbearing potential (< 1 year amenorrheic) or sexually active males who are not employing adequate contraception (or practicing complete abstinence); female patients of childbearing potential must commit to using a reliable and appropriate method of contraception until at least 7 months after the end of last dose of study treatment; male patients with a partner of childbearing potential must agree to use a barrier method of contraception (condom) in addition to having their partner use another contraceptive method during the trial and for 7 months after the last dose of study treatment; examples of reliable and appropriate methods of contraception include hormonal implants, oral contraceptives, intra-uterine devices, or a barrier method used in conjunction with spermicidal jelly
Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception from the time of informed consent until 23 weeks after treatment discontinuation
Of child-bearing potential, Subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device from the time of signing the informed consent through at least 4 weeks after the last dose of study drug. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
If of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of study medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of study medication.
If female of child-bearing potential (i.e. not postmenopausal or surgically sterile), must be willing to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods. If male, must be sterile or willing to abstain from sexual intercourse or employ a barrier method of contraception during the study treatment and follow-up periods.
If of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
If female of child-bearing potential (i.e. not postmenopausal or surgically sterile), must be willing to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and for at least 6 months following last treatment. If male, must be sterile or willing to abstain from sexual intercourse or employ a barrier method of contraception during the study treatment and for at least 6 months following last treatment.
Acceptable method of contraception
IUD plus one barrier method;
Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method;
PHASE I: Sexually active male subjects must use an effective method of contraception (barrier method of birth control or abstinence) from the time of consent until at least 180 days following discontinuation of protocol therapy
PHASE IB: Sexually active male subjects must use an effective method of contraception (barrier method of birth control or abstinence) from the time of consent until at least 180 days following discontinuation of protocol therapy
All females of childbearing potential must use an effective barrier method of contraception (either an intrauterine device contraceptive [IUDC] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter; male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter; female subjects should avoid the use of estrogen-containing contraceptives
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation
For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib
Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Subject's partner must also use barrier protection while subject is on study until 4 weeks after treatment discontinuation.
Males must be willing to use an effective method of contraception/method to avoid seminal transfer (barrier method or abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Subject's partner must also use barrier protection while subject is on study until 4 weeks after treatment discontinuation.
Females of childbearing potential, and males, must be willing to use an effective method of contraception
Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 24 weeks (6 months) after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label
All women of childbearing potential must agree to use an effective barrier method of contraception during the treatment period and for at least 1 month after discontinuation of the study drug; male subjects should use effective barrier method of contraception during the treatment period and for at least 1 month after discontinuation of the study drug
Negative urine or serum pregnancy test for women of childbearing potential; all women of childbearing potential must agree to use an effective barrier method of contraception (either an intrauterine device [IUD] or double-barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month after discontinuation of the study drugs; male subjects should use effective barrier method of contraception during the treatment period and for at least 3 months after discontinuation of the study drugs
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Females of childbearing potential and males must be willing to abstain from heterosexual activity or must agree to use adequate contraception (hormonal or barrier method) for the duration of study participation and for 3 weeks after discontinuation of study treatment.
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
CELL PROCUREMENT: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 3 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol\r\n* Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the last dose of study therapy
LYMPHODEPLETION: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 3 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol
iC9-CAR19 CELL INFUSION: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 3 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol
Females and males of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 12 weeks (for males) and 5 months (for females) after treatment discontinuation
Females of childbearing potential and male subjects with female partners of childbearing potential must agree to avoid pregnancy by using an adequate method of contraception (2 barrier method or 1 barrier method with a spermicide or intrauterine device for 2 weeks prior to screening, during and 12 weeks after the last dose of trial medication; adequate methods of contraception are provided as examples; other acceptable and effective methods of birth control are also permitted (e.g., abstinence)
Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to the first dose of trial treatment; they must also agree to two barrier methods or a barrier method plus a hormonal method, or agree to abstain from heterosexual activity, for the course of the study through 120 days after the last dose of trial treatment; females who have been surgically sterilized or are free from menses for > 1 year (postmenopausal) may enroll
Female subjects may be enrolled in the trial if they are: \r\n* of non-childbearing potential which is defined as: \r\n* of childbearing potential who are willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity throughout the trial, starting with the screening visit (visit 1) through 120 days after the last dose of MK-3475 (pembrolizumab)
Negative urine or serum pregnancy test for females of childbearing potential; all females of childbearing potential must use an effective barrier method of contraception (either an intrauterine device [IUD] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter; male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation
Female patients of childbearing potential must be willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study, starting with visit 1
Sexually active patients of childbearing potential must be willing to use an acceptable method of contraception such as an intrauterine device or double barrier contraception during treatment and for 45 days after the last dose of study drug (hormonal contraception is not allowed)
For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of MK-3475
Men must be willing not to father a new child while receiving therapy; they must use an effective barrier method of contraception during the study and for 3 months following the last dose
Condom (barrier method of contraception) AND
Patients of childbearing or child-fathering potential must be willing use an effective method of contraception while being treated on this study and for 4 months after the last cell infusion
Able and willing to use double barrier method of contraception for at least 3 months prior to ST-400 infusion and through 6 months post-transplant
Women of childbearing potential and males must be willing to use an effective method of contraception from the time consent is signed until 4 weeks after treatment discontinuation
Females: Pregnant or breast?feeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial.
In women who have not experienced menopause, negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment. Adequate forms of contraception include:\r\n* 2 adequate barrier methods\r\n* A barrier method plus a hormonal method of contraception\r\n* Abstaining from sexual activity throughout the trial, starting with the screening visit through 120 days after the last dose of pembrolizumab.
Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label
Males and females of child-bearing potential*, willing to use an effective form of contraception during chemotherapy treatment and for at least 6 months thereafter. Such methods include: (if using hormonal contraception this method must be supplemented with a barrier method, preferably male condom)
Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception from the time of informed consent until 5 months after treatment discontinuation. Women cannot breast feed from the time of informed consent to 5 months after last dose of study treatment.
Females of childbearing potential, and males, must be willing to use an effective method of contraception
All subjects, including those who are surgically sterilized, must be willing to use an effective method of contraception (barrier method of birth control or abstinence) from the time informed consent is signed until 6 months after completion of protocol therapy
Female patients of childbearing potential (a female not free from menses > 2 years or not surgically sterilized) must be willing to use an adequate barrier method of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study; male patients who are able to father children must use an adequate barrier method of contraception
DONOR: Breast feeding or pregnant females; donors of childbearing potential must use an effective method of contraception during the time they are receiving filgrastim
Condom (barrier method of contraception), and 2. One of the following:
use an effective barrier method of contraception
All subjects, including those who are surgically sterilized, must be willing to use an effective method of contraception (barrier method of birth control or abstinence) from the time informed consent is signed until 6 months after completion of protocol therapy.
Males and females of childbearing potential must agree to use protocol-specified method(s) of contraception
Women of childbearing potential and males must be willing to use an effective method of contraception from the time consent is signed until 4 weeks after treatment discontinuation.
Patient must be willing to practice two forms of contraception, one of which must be a barrier method, from study entry until at least 35 days after the last dose of the study drug.
Condom (barrier method of contraception); AND
Males and females of childbearing potential must agree to use protocol-specified method(s) of contraception
All females of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device [IUDC] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter; male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter; female subjects should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives
Patient agrees to use an effective method of contraception (hormonal or two barrier methods) while on study and for at least 3 months following the plerixafor infusion
Condom (barrier method of contraception), AND
Women and men of childbearing potential must be willing to use an effective method of contraception (e.g. hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after protocol therapy discontinuation.
For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib
Females of childbearing potential, and males, must be willing to use an effective method of contraception
Condom (barrier method of contraception) AND
Women of childbearing potential must have negative urine pregnancy test. Sexually active women must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes IUD plus one barrier method; on stable doses of hormonal contraception for at least 3 months plus one barrier method; 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides; or vasectomized partner
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Female patients of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
For male individuals having intercourse with females of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol- recommended method of contraception
Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted participants for 18 months after the first dose of study therapy; for the first 60 days post-transplant, recipients should be encouraged to use non-hormonal contraceptives; if using a barrier method, a double barrier method should be used
Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal, barrier method of birth control or abstinence) from the time the consent is signed, during the duration of study participation and 4 months after discontinuation of protocol therapy
For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days of the first administration of study treatment and must be willing to use two methods of contraception one of them being a barrier method or abstain from sexual activity during the study and for 3 months after last study drug administration; sexually active males and their female partners must agree to use two methods of accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study
Use of an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for men and women of childbearing potential while enrolled in the study
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Women of childbearing potential who are not using a reliable method of contraception; methods of contraception that are considered reliable are intrauterine devices (IUDs), birth control pills, hormonal implants/patches, and barrier contraception when used with spermicidal products; the “rhythm method” is not considered a reliable method of contraception
If of childbearing potential (males and females), willing to use an effective form of contraception such as latex condom, hormonal birth control, intrauterine device or double barrier method during chemotherapy treatment and for at least six months thereafter
Female subjects of childbearing potential and all male subjects are required to consent to use a medically acceptable method of contraception throughout the study period and for 30 days after amatuximab administration; a barrier method of contraception is required
If of childbearing potential, is willing to abstain for sexual intercourse or to use an effective form of contraception (double-barrier method) during the study and for 90 days following the last dose of ganetespib